[Federal Register: November 1, 2006 (Volume 71, Number 211)]
[Notices]
[Page 64282-64284]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01no06-89]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Information (RFI): Improving Health and Accelerating
Personalized Health Care Through Health Information Technology and
Genomic Information in Population- and Community-Based Health Care
Delivery Systems
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Advances in medicine, biomedical science, and technology
present opportunities for enabling health care practices to be
increasingly patient-specific by taking into account individual
differences in health states, disease processes, and outcomes from
interventions. Often referred to as personalized health care, the
desired impact of these types of health practices is improved
effectiveness and safety of medical practices. These health benefits
may be manifested through new approaches for predicting disease risk at
an early time point, enabling preemption of disease processes prior to
full manifestation of symptoms, analyzing the effectiveness of
different interventions in specific populations based on their genetic
makeup, and preventing the progression of disease and the related
complications.
For the purpose of achieving a broader understanding of rapid
changes occurring in the health care setting that may have an impact on
the future of personalized health care, the Department of Health and
Human Services (HHS) requests input from the public and private sectors
on plans for developing and using resources involving health
information technology (IT) and genetic and molecular medicine, with
specific reference to incorporating these capacities in evidence-based
clinical practice, health outcomes evaluations, and research.
DATES: Responses should be submitted to the Department of Health and
Human Services on or before 5 p.m., EDT, January 2, 2007.
ADDRESSES: Electronic responses are preferred and may be addressed to
PHCRFI@hhs.gov. Written responses should be addressed to Department of
Health and Human Services, 200 Independence Avenue, SW., Room 434E,
Washington, DC 20201, Attention: Personalized Health Care RFI.
A copy of this RFI is also available on the HHS Web site at http://www.aspe.hhs.gov/PHC/rfi.
Please follow the instructions for submitting
responses.
The submission of written materials in response to the RFI should
not exceed 75 pages, not including appendices and supplemental
documents. Responders may submit other forms of electronic materials to
demonstrate or exhibit key concepts of their written responses.
Public Access: Responses to this RFI will be available to the
public in the HHS Public Reading Room, 200 Independence Avenue, SW.,
Washington, DC 20201. Please call (202) 690-7453 between 9 a.m. and 5
p.m. to arrange access. The RFI and all responses will also be made
available on the HHS Web site at http://www.aspe.hhs.gov/PHC/rfi. Any
information you submit will be made public.
Do not send proprietary, commercial, financial, business
confidential, trade secret, or personal information that should not be
made public.
FOR FURTHER INFORMATION CONTACT: Dr. Gregory Downing, Personalized
Health Care Initiative, (202) 260-1911.
SUPPLEMENTARY INFORMATION: Advances in medicine, biomedical science,
and technology present opportunities for enabling health care practices
to be increasingly patient-specific by taking into account individual
differences in health states, disease processes, and outcomes from
interventions. Often referred to as personalized health care, the
desired impact of these types of health practices is improved
effectiveness and safety of medical practices. These health benefits
may be manifested through new approaches for predicting disease risk at
an early time point, enabling preemption of disease processes prior to
full manifestation of
[[Page 64283]]
symptoms, analyzing the effectiveness of different interventions in
specific populations, and preventing the progression of disease and the
related complications.
The application of interoperable electronic information
technologies (IT) in the health care setting provides new opportunities
to collect and analyze information about diagnostic and therapeutic
interventions, as well as health care outcomes. With many potential
applications, integrated data analysis of multiple parameters of health
care practices has the potential to support new approaches to
evaluating health outcomes, developing the evidence base for best
practices, identifying individual differences in response to therapies,
supporting research on new interventions, automating the process of
detecting and reporting notifiable disease conditions and health care-
associated infections to public health surveillance systems, and
enhancing safety.
In the past year, the American Health Information Community (AHIC),
a chartered Federal advisory committee, has made recommendations to the
Secretary to advance the development of electronic health records
(EHR). AHIC's activities and recommendations support a nationwide
approach to developing digital and interoperable health IT systems that
ensure the privacy and security of patient information. Already
underway are efforts to support consumer empowerment, health safety and
improvement, and public health protection through broadly deployed,
harmonized information systems. As a result of the deployment of these
capabilities throughout the health care system, new avenues are
emerging to apply information about individual health experiences
toward improved transparency about the quality and cost of health care
and transformation of health care delivery, as well as decision support
for health practitioners.
Occurring in parallel with the advances in health IT are advances
in molecular and genetic medicine. This science-based approach to
medicine is now in the early stages of entry in health care through the
introduction of diagnostics and treatments that target specific genetic
and molecular features of disease processes. Applications of this
science and technology provide useful information to aid in patient
care through more accurate diagnosis and treatment at an individual
level. The availability of genetic information (especially the
availability of this information as part of the EHR), and the ability
to aggregate these data and correlate them with outcomes or other
relevant findings from multiple sources, could greatly expand our
capacity for personalized health care, providing more specific
individual information for prevention, diagnosis, and treatment;
pointing toward clinically useful markers; enabling safer and more
effective use of existing therapies; and identifying potential fruitful
areas for development of new or refined therapies.
New pathways are emerging for affordable and more effective health
care practices through personalized health care. The ability to
integrate new scientific knowledge, especially our growing
understanding of the human genome, into the health care setting in an
efficient and timely fashion will rely on robust, reliable and secure
information sources in electronically interoperable systems. Many
public and private organizations are engaged in the planning for future
collections and integration of health data for this purpose. This
request seeks information that will facilitate a broader understanding
of directions being taken and the productive role that Federal health
agencies might play in facilitating progress, avoiding unnecessary
barriers, and achieving optimal benefit from the opportunities now
before us.
Information Requested
For the purpose of achieving a broader understanding of rapid and
emerging changes occurring in the health care setting that may have an
impact on the future of personalized health care, HHS requests input
from interested parties on plans for developing and using resources
involving health IT and genetic and molecular medicine, with specific
reference to incorporating these capacities in evidence-based clinical
practice, health outcomes evaluations, research, and transformation of
health care delivery.
Input is sought on the interest and current planning activities of
health care systems and related organizations on the needs and
applications of these transformative aspects of personalized health
care. Specific areas for comment include:
Concepts on anticipated approaches for the use of EHR and
population- and community-based health care system databases for
longitudinal data collection in addressing:
--Disease susceptibility.
--Clinical course and outcomes.
--Treatment response.
--Evidenced-based clinical decision support.
--Optimal healthcare delivery systems.
Anticipated applications of genomic-based clinical testing
in medical decision-making, safety assessment, and risk management.
Establishment of biospecimen resources obtained from
clinical medical services for application in research, clinical trials,
health services planning, clinical effectiveness, and health outcomes
evaluations.
Organizational or institutional practices to address
ethical, legal, and social implications regarding the use of patient
information, including genetic data, to support personalized health
care.
Examples of utilizing large clinical data repositories for
practical clinical research to discover effective technologies,
therapeutics, diagnostics, and prevention strategies for different
populations.
Issues and challenges associated with incorporating
genomic information as a part of a broad longitudinal data collection.
Needs for community-wide standards or best practices that
will facilitate large-scale data integration and exchange to benefit
personalized health care.
Feasibility and potential benefits for establishing
linkages of institutional or organizational data resources with private
and publicly available health databases.
Development of ontologies across different clinical data
repositories that will facilitate the utility of the data for answering
clinical research questions.
Models for linking clinical data repositories across
disparate care providers.
Examples of the use of disease registries to track
specific diseases and response to drug therapies across different
subpopulations.
Models for prioritizing analyses to fill gaps in evidence
of effectiveness of therapeutic interventions for different
populations.
Strategies for accumulating patient data necessary for
research that may not be available through EHRs.
Concepts or models on the potential use of clinical data
and related resources for research applications.
Models of cost-benefit analysis for integrated data
systems, EHR, and clinical resources to inform medical decision-making.
Opportunities and challenges for the development of
electronic tools to aid in the integration and analysis of large
datasets of clinical parameters to assist in outcomes evaluations.
Potential Responders
HHS anticipates responses from a broad range of individual
organizations
[[Page 64284]]
that have interests in health systems change and personalized health
care. Some examples of these organizations include:
Community health delivery systems.
Health maintenance organizations.
University-based health systems.
State and local public health departments.
Other Federal agencies.
Advocacy groups and public interest organizations.
Consumer and patient interests groups.
Health care professional societies.
Trade industry organizations.
Purchasers of health care.
Health information technology industry vendors.
Dated: October 26, 2006.
John O. Agwunobi,
Assistant Secretary for Health, Office of Public Health and Science.
[FR Doc. E6-18371 Filed 10-31-06; 8:45 am]
BILLING CODE 4150-26-P